Rixacam

Leaflet accompanying the packaging: patient information

RIXACAM, 15 mg, hard capsules

Rivaroxaban

You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is RIXACAM and what is it used for
• 2. Important information before taking RIXACAM
• 3. How to take RIXACAM
• 4. Possible side effects
• 5. How to store RIXACAM
• 6. Contents of the packaging and other information

1. What is RIXACAM and what is it used for

RIXACAM contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, if you have a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

RIXACAM is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

RIXACAM belongs to a group of medicines called anticoagulants. Its action is based on blocking a blood clotting factor (factor Xa) and thus reducing the tendency to form blood clots.

2. Important information before taking RIXACAM

When not to take RIXACAM

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of an organ that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgical procedure on the brain or eyes),
• if you are taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or

if heparin is administered to maintain the patency of a vein or artery catheter,

• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take RIXACAM, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take RIXACAM, you should consult your doctor or pharmacist.

When to be particularly careful when taking RIXACAM

• if you have an increased risk of bleeding, such as severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine that works in your body, taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran etexilate, apixaban, or heparin) when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "RIXACAM and other medicines"), bleeding disorders, very high blood pressure that does not decrease despite treatment, diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system, disease of the blood vessels in the back of the eyeballs (retinopathy), lung disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic valves,
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment,
• if you have abnormal blood pressure or a surgical procedure is planned to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, you should inform

your doctorbefore taking RIXACAM. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• it is very important to take RIXACAM exactly as directed by your doctor before and after surgery;
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief): it is very important to take RIXACAM exactly as directed by your doctor before and after the puncture or catheter removal; you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder dysfunction, as immediate treatment may be necessary.

Children and adolescents

RIXACAM 15 mg capsules are not recommended for children with a body weight below 30 kg.There is a lack of sufficient data on the use of rivaroxaban in children and adolescents for adult indications.

RIXACAM and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If you are takingcertain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines used to treat bacterial infections (e.g., clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir), other medicines used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol), anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that any of the above applies to you, you should inform

your doctorbefore taking RIXACAM, as the effect of RIXACAM may be enhanced. Your doctor will decide whether to use this medicine and whether you should be under close observation.
If your doctor believes that you have an increased risk of stomach or duodenal ulcers, they may use a treatment to prevent stomach ulcers.

• If you are takingcertain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort (Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, which belongs to a group of antibiotics.

If you suspect that any of the above applies to you, you should inform

your doctorbefore taking RIXACAM, as the effect of RIXACAM may be reduced. Your doctor will decide whether to use RIXACAM and whether you should be under close observation.

Pregnancy and breastfeeding

Do not take RIXACAM if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception during RIXACAM treatment. If you become pregnant during RIXACAM treatment, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

RIXACAM may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive vehicles, ride bicycles, or operate tools or machines.

RIXACAM 15 mg contains lactose monohydrate (a type of sugar) and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means that the medicine is considered "sodium-free".

3. How to take RIXACAM

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
RIXACAM should be taken with food.
The capsule(s) should be swallowed whole, preferably with water.
If you have difficulty swallowing the whole capsule, you should talk to your doctor about other ways to take RIXACAM. The contents of the capsule can be mixed with water or apple sauce just before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also administer the contents of the RIXACAM capsule through a gastric tube.

How many capsules to take

Adults

In the prevention of blood clots in the brain (stroke) and other blood vessels in the body.

The recommended dose is one RIXACAM 20 mg capsule once a day.
If you have kidney problems, the dose may be reduced to one RIXACAM 15 mg capsule once a day.
If you need a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one RIXACAM 15 mg capsule once a day (or one RIXACAM 10 mg capsule once a day in case of kidney function impairment) in combination with an antiplatelet medicine such as clopidogrel.

In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots

The recommended dose is one RIXACAM 15 mg capsule twice a day for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one RIXACAM 20 mg capsule once a day.
After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg capsule once a day or one 20 mg capsule once a day.
If you have kidney problems and are taking one RIXACAM 20 mg capsule once a day, your doctor may decide to reduce the dose to one RIXACAM 15 mg capsule once a day after 3 weeks of treatment, if the risk of bleeding is higher than the risk of recurrent blood clots.

Children and adolescents

The dose of RIXACAM depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one RIXACAM 15 mgcapsule once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one RIXACAM 20 mgcapsule once a day.

Each RIXACAM dose should be taken with food, with a drink (e.g., water or juice). The capsules should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you.
For parents or caregivers: you should observe the child to make sure they have taken the entire dose.
The dose of RIXACAM depends on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose of RIXACAM yourself.If necessary, your doctor will adjust the dose.
Do not sprinkle the contents of the capsule to obtain a partial dose. If a smaller dose is needed, you should use a different medicine containing rivaroxaban in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole capsules, you should use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, you can sprinkle the contents of the RIXACAM capsule and mix it with water or apple sauce just before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also administer the sprinkled contents of the RIXACAM capsule through a gastric tube.

If you spit out a dose or vomit

• less than 30 minutes after taking RIXACAM, you should take a new dose.
• more than 30 minutes after taking RIXACAM, do not takea new dose. In this case, the next RIXACAM dose should be taken at the usual time.

You should consult your doctor if you spit out a dose or vomit repeatedly after taking RIXACAM.

When to take RIXACAM

The capsule(s) should be taken every day until your doctor decides to stop the treatment.
It is best to take the capsule(s) at the same time every day, as it is easier to remember.
Your doctor will decide how long you should continue the treatment.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, you should take RIXACAM as directed by your doctor.

Taking a higher dose of RIXACAM than recommended

If you have taken a higher dose of RIXACAM than recommended, you should immediately consult your doctor. Taking too much RIXACAM increases the risk of bleeding.

Missing a dose of RIXACAM

Adults, children, and adolescents:
If you are taking one 15 mg capsule oncea day and you miss a dose, you should take it as soon as possible. Do not take more than one capsule in a 24-hour period to make up for the missed dose. The next capsule should be taken the next day, and then you should continue taking one capsule once a day.
Adults:
If you are taking one 15 mg capsule twicea day and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg capsules in a 24-hour period. If you miss a dose, you can take two 15 mg capsules at the same time to take the total daily dose of 30 mg. The next day, you should continue taking one 15 mg capsule twice a day.

Stopping RIXACAM treatment

You should not stop taking RIXACAM without first consulting your doctor, as RIXACAM treats and prevents serious diseases.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIXACAM can cause side effects, although not everybody gets them.
Like other medicines with similar effects that reduce blood clotting, RIXACAM can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). The signs of bleeding may not always be obvious or visible.

You should immediately inform your doctor if you experience any of the following side effects:

• Signs of bleeding:
• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives, and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum when coughing (hemoptysis),
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from a wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (which can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (which can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

Frequency not known(frequency cannot be estimated from the available data)

• kidney failure after severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:

• Very common(may affect more than 1 in 10 people)
• headache
• fever
• nasal bleeding
• vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should consult your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RIXACAM

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP or expiry date. The expiry date refers to the last day of the month.
PVC/PVdC/Alu blisters: Store in a temperature below 30°C.
Store in the original packaging to protect from moisture.
Aluminium/OPA/Aluminium/PVC blisters: There are no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What RIXACAM contains

• The active substance of RIXACAM is rivaroxaban. Each capsule contains 15 mg of rivaroxaban.
• The other ingredients are: capsule contents:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. capsule shell:gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

What RIXACAM looks like and contents of the pack

RIXACAM 15 mg: light brown, opaque capsules filled with white or almost white powder, size "1" (approximately 19 mm long).
The hard capsules are packaged in PVC/PVdC/Alu or Aluminium/OPA/Aluminium/PVC blisters and cartons.
RIXACAM 15 mg capsules: available in packs of 14, 28, 42, or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola
PLA3000, Malta
Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3,
Bucharest, 032266
Romania
RIXACAM 15 mg is authorized for marketing in the Member States of the European Economic Area under the following names:
Czech Republic, Poland: RIXACAM
Spain: RIXACAM 15 mg hard capsules

Date of last revision of the leaflet: